Quality Assurance Manager

About the Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience — and products and services in our Allergan Aesthetics portfolio.

About the Role

The Quality Assurance Manager is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, Compendia management and CAPA.

Responsibilities

• Translate strategy into tactical objectives to deliver strategic plans and regulatory updates.
• Ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
• Provide direction to staff of professionals to include hiring, setting performance expectations, performance feedback and development of staff.
• Direct the development of Quality policies that meet both regulatory and company requirements.
• Maintain expertise on various regulations (FDA, EMA, ICH, etc.).
• Provide compliance leadership to the manufacturing site.
• Serve as direct interface with FDA and other regulatory agencies and customers during inspections.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Review and approve deviation investigations, driving reduction in quality events through robust CAPA.
• Compile, analyze and communicate significant quality or compliance metrics to senior management.
• Establish programs to promote quality awareness and compliance.

Requirements

• Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
• 8+ years experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and in leading cross-functional teams.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently.
• Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) and written communication skills.
• Excellent interpersonal skills.
• Ability to lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.

Pay

The compensation range described is the range of possible base pay that AbbVie believes in good faith it will pay for this role at the time of posting, based on the job grade. Individual compensation paid within this range will depend on many factors including geographic location, and may ultimately differ from the posted range. This range may be modified in the future.